Helius Medical touts PoNS TBI-treatment trial data despite primary effectiveness miss

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Helius MedicalHelius Medical Technologies (TSX:HSM) today released results from a registrational trial of its Portable Neuromodulation Stimulator, used to treat patients with chronic balance deficits due to mild-to-moderate traumatic brain injuries, touting positive effects but a missed primary effectiveness endpoint.

The Newtown, Penn.-based company’s PONS system is designed to treat neurological symptoms, caused by trauma or disease, non-invasively through the tongue.

“We are excited to be on the forefront of research that may bring this novel and exciting therapy to patients in need. The investigators and research teams from the Montreal Neurofeedback Center, Orlando Regional Medical Center, Oregon Health and Sciences University, Health Tech Connex, Inc., Virginia Commonwealth University, MedStar National Rehabilitation Hospital and University of Wisconsin – Madison are pleased with the execution of this study and look forward to further analysis and publication of the results,” study coordinating principal investigator Dr. Alain Ptito of the McGill University Health Centre said in a prepared statement.

The 122-patient double-blind, randomized, sham-controlled trial aimed to explore the safety and effectiveness of the PoNS system for treating chronic balance deficits due to mild or moderate TBIs, and evaluated them over 5 weeks of treatment.

Endpoints for effectiveness were assessed with the Sensory Organization Test. The primary endpoint was a responder rate analysis with responders defined as subjects with an improvement of at least 15 points on the composite SOT scores compared to baseline.

Secondary effectiveness endpoints relied on the outcome of the primary endpoint and clinical effectiveness. Safety endpoints were assessed by the frequency of falls, headaches and adverse events.

Effectiveness results indicated that treatment with the PoNS therapy had a trend toward a higher responder rate in the active PoNS therapy group versus the control at 75.4% versus 60.7%.

The company said that the primary effectiveness endpoint in the trial was not reached because the control group, which used low frequency pulse treatment instead of high frequency treatment with the PoNS, was found to have had a significant therapeutic effect.

Secondary effectiveness endpoints showed “statistically and clinicaly significant increases” of at least 8 points, with mean improvement in composite SOT socres of 18.3 points at 2 weeks and 24.6 points at 5 weeks. No serious device related adverse events were reported.

“We are very pleased with the findings from our registrational trial that demonstrate that PoNS Therapy, deployed independently across our seven study sites, produced statistically significant improvements in balance from baseline, on average over three times the clinically significant amount. Achieving the safety endpoints and further growing a positive safety profile continues to build confidence in our technology. With an underserved patient population waiting for improved treatment opportunities, we are eager to move forward with our applications for clearance with the U.S. Food and Drug Administration and other foreign regulatory bodies,” Helius chief medical officer Dr. Jonathan Sackier said in a press release.

“This is a very exciting and promising milestone for our company, patients and the healthcare community. Our next steps include compiling the clinical evidence produced from this registrational trial and previous studies investigating the PoNS treatment, as well as verifying and validating product design improvements and manufacturing to be included in our regulatory application. We are working to submit our 510(K) application to the U.S. FDA in the first half of 2018, with clearance anticipated in the second half of 2018,” Helius CEO Philippe Deschamps said in prepared remarks.

In April, Helius said it inked a 5-year lease on a piece of property that will serve as its corporate headquarters.

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